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Biguanide
Metformin for Breast Cancer Prevention
Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Known breast cancer (BRCA)1 or BRCA2 mutation carrier providing that the woman has met with a genetic counselor to review genetic testing results, and has been offered the opportunity to undergo prophylactic mastectomy and oophorectomy
Women eligible to take tamoxifen must be offered tamoxifen prevention as part of their clinical care and have refused tamoxifen treatment
Must not have
Receiving Warfarin
Currently receiving tamoxifen or raloxifene
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial compares metformin to placebo to see if it can prevent breast cancer.
Who is the study for?
This trial is for women at high risk for breast cancer due to factors like a history of certain breast conditions, a strong family history of breast or ovarian cancer, or known BRCA1/2 mutations. Participants must have normal blood counts and organ function, not be pregnant or breastfeeding, and willing to use birth control if menstruating. They should not have had metformin recently, no other active cancers (with some exceptions), and cannot be on specific medications like Warfarin.
What is being tested?
The study is testing whether metformin hydrochloride can prevent the development of breast cancer in patients with atypical hyperplasia or in situ breast cancer compared to a placebo. It's a phase III trial where participants are randomly assigned to either the drug group or the placebo group.
What are the potential side effects?
Potential side effects from metformin may include digestive issues such as nausea and diarrhea, potential vitamin B12 deficiency with long-term use, and rarely lactic acidosis—a serious metabolic complication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I carry a BRCA1 or BRCA2 mutation and have discussed my options with a genetic counselor.
Select...
I am eligible for tamoxifen but have chosen not to take it.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking Warfarin.
Select...
I am currently taking tamoxifen or raloxifene.
Select...
I have had breast reconstruction with implants or my own tissue.
Select...
I am allergic to metformin.
Select...
I have had radiation therapy on both breasts.
Select...
I am currently taking pyrimethamine, cimetidine, rifampin, or cephalexin.
Select...
My hemoglobin A1c is above 6.3 or I am being treated for diabetes.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I have had a biopsy showing invasive cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2023 Phase 3 trial • 3649 Patients • NCT0110143845%
Diarrhea
45%
Fatigue
39%
Hot flashes
31%
Nausea
27%
Peripheral sensory neuropathy
23%
Insomnia
21%
Arthralgia
18%
Pain in extremity
17%
Headache
16%
Constipation
14%
Pain
14%
Anxiety
13%
Depression
12%
Back pain
12%
Myalgia
11%
Abdominal pain
11%
Hypertension
11%
Alopecia
10%
Anorexia
10%
Dyspepsia
10%
Bloating
9%
Weight loss
9%
Flatulence
9%
Lymphedema
9%
Cough
9%
Dyspnea
8%
Vomiting
8%
Edema limbs
8%
Dizziness
7%
Gastroesophageal reflux disease
7%
Dermatitis radiation
6%
Breast pain
5%
Weight gain
5%
Arthritis
5%
Bone pain
5%
Dysgeusia
5%
Vaginal dryness
4%
Hyperglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Metformin
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I: metformin hydrochlorideExperimental Treatment1 Intervention
Patients receive metformin hydrochloride PO QD or BID for 24 months. Patients will continue metformin 850 mg PO BID for months 13-24. Patients will undergo RPFNA at 24 months. Follow up visits will be performed at 36 and 48 months after the start of treatment.
Group II: Arm II: placeboPlacebo Group1 Intervention
Patients receive placebo PO QD or BID for 12 months. Patients may crossover to Arm I for months 13-24.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
metformin hydrochloride
2010
Completed Phase 3
~5940
Find a Location
Who is running the clinical trial?
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,311 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,839 Total Patients Enrolled
Victoria Seewaldt, MDStudy ChairCity of Hope Comprehensive Cancer Center
1 Previous Clinical Trials
344 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently diagnosed with alcoholism.I have taken metformin in the last 90 days.I am eligible for tamoxifen but have chosen not to take it.Your AST blood test result is not more than three times the upper limit of normal.I haven't had cancer, except for non-melanoma skin cancer or cervical pre-cancer, in the last 5 years.Women who can have children must have a negative pregnancy test within 7 days before joining the study.You weigh less than what is considered healthy for your height.I am currently taking Warfarin.I am currently taking tamoxifen or raloxifene.Your hemoglobin level is at least 9 grams per deciliter.Your creatinine level in the blood is no higher than 1.4 milligrams per deciliter.Your total bilirubin level must be less than or equal to 3.0 mg/dL.I have had breast reconstruction with implants or my own tissue.I am allergic to metformin.I have had radiation therapy on both breasts.I am currently taking pyrimethamine, cimetidine, rifampin, or cephalexin.My hemoglobin A1c is above 6.3 or I am being treated for diabetes.I am at high risk for breast cancer due to my medical or family history.I carry a BRCA1 or BRCA2 mutation and have discussed my options with a genetic counselor.I am considered pre-menopausal based on my recent menstrual cycles or hormone levels.My last mammogram was normal or showed no signs of invasive breast cancer.I am not pregnant or breastfeeding and have been using birth control if I am menstruating.My breast test score is 14-17 and was sent to Dr. Seewaldt's lab within the last 3 months.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.Your ALT level in the blood should be no more than three times the upper limit of normal.You must have at least 75,000 platelets per cubic millimeter of blood.I have had a biopsy showing invasive cancer.You have a sufficient number of a type of white blood cell called neutrophils.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I: metformin hydrochloride
- Group 2: Arm II: placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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